EDITORS' DESK

  • End Of An Outsourcing Era: Quality And Procurement In Balance
    End Of An Outsourcing Era: Quality And Procurement In Balance

    For those in drug development and manufacturing outsourcing through the first decade and a half of this new century, it’s now safe to glance back … and finally put an end to an era focused on costs. A look back, and prognosis for what comes next, in an interview with William A. (Al) Kentrup, VP Global Quality Compliance and Systems, Takeda Pharmaceutical Company.

It Could Be At Takeda Or P&G: The Three Pieces of Outsourcing

Three pieces for working with contractors and external supply-chains are Communication, Transparency for Problem Resolution, and Benefit Sharing, says William A. (Al) Kentrup, VP Global Quality Compliance and Systems, Takeda Pharmaceutical Company, and former director of corporate quality at Procter and Gamble.

The Three Pillars Of Industry Conferences

Every organization – and each individual within – has specific needs and objectives for attending industry conferences. Yet, we can identify three overarching criteria: Go where you can meet customers; Go where you can learn; Go where you can participate. Here’s a look at the possibility of putting all three into practice.

M&A Crucible in Contract Drug Development And Manufacturing

According to a new industry report, the major contract development and manufacturing organizations only command a 2-4% market share each. Nonetheless, there is substantial M&A activity in the sector, and it certainly feels like we’re on a cusp of major consolidation. Let’s look at the evidence and momentum.

Adversity On The Path to Global Drug Distribution

Not all Outsourced Pharma readers will have had experiences as pronounced as Jennifer Dent’s. But her narrative can spur us to take a look at our own personal – and organizational – missions within the greater biotech and pharma realm, and point to another area where outsourcing drug development and manufacturing professionals can step up our global leadership.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • Biosimilars & Generics: Are The Market Comparisons Valid?
    Biosimilars & Generics: Are The Market Comparisons Valid?

    The U.S. biosimilar market is in its infancy, with only four products approved by the FDA and only two currently on the market. Passed over 30 years ago, the Hatch-Waxman Act, which allowed generic competition for branded drugs, has proven successful in decreasing drug prices while still encouraging innovation. Will the availability of biosimilars have a similar effect on the biologics market? There has been much debate in the industry concerning the future of biosimilars and how analogous they are to the generic market.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)
    5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)

    This article explains the critical components of a compliant disinfectant efficacy testing package in the U.S.,  along with tips for assembling the package.

  • How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)
    How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  •  What Outcomes-Based Contracting Means For Drug Development & Drug Pricing
    What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

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PHARMA OUTSOURCING WHITE PAPERS

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ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  • Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies
    Packed Session Illustrates Reason For Excitement Around Advanced Cancer Therapies

    There are many reasons to be excited by the science being presented at this year’s American Society for Clinical Oncology meeting. The data presented at a special section on Saturday morning opened the door to a future when tumor genetics and biomarkers will change the way we think of about cancer treatment. As a physician working in clinical development, there is also the excitement around intriguing new questions that when answered could lead to life-saving treatments unimaginable just a decade ago. 

    More than 2,000 people packed into a cavernous conference hall at 8 a.m. on Saturday – demonstrating the high level of shared interest in emerging immunotherapies.  

  • Shift From Central Lab To POC
    Shift From Central Lab To POC

    As new technologies work to change the market space, this article takes a look at the market forces that are helping and hindering the shift to zero wait time for patient test results. Comprehensive analysis of both test settings allows for better understanding of the diagnostic landscape as it exists today, offering insight to both product and process innovations for your next generation product.

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  • NEW DOCUMENT

    Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.

     

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OUTSOURCING EVENTS

Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success April 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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